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High Resolution Gastric Mapping and Gastroduodenal Manometry

NCT06941545 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-08-19

No results posted yet for this study

Summary

Dyspepsia is a common problem attributed to gastric sensorimotor dysfunctions ie, delayed, or less frequently rapid gastric emptying (GE), impaired gastric accommodation, and increased gastric sensation. Therapeutic options manage symptoms, and there is no FDA approved medical therapy for dyspepsia. There is a need for better objective understanding of sensorimotor dysfunction in dyspepsia, as well as noninvasive, efficacious, safe, and inexpensive treatments for dyspepsia.

The purpose of this research is to identify disturbances and characterize phenotypes in patients with functional dyspepsia, and to assess the correlations between symptoms (during the manometry and in daily life), gastric emptying, electrical activity (BSGM), and pressure activity (manometry).

Conditions

  • Dyspepsia

Interventions

DEVICE

Alimetry

High resolution gastric mapping of electrical gastric activity.

DEVICE

tVNS

Transcutaneous Auricular Vagal Nerve Stimulation, electrical stimulation to the ear.

DEVICE

Gastroduodenal Manometry

Pressure catheter evaluating gastric and duodenal pressure profiles at rest and with certain stimuli applied

Sponsors & Collaborators

Principal Investigators

  • Nicholas R Oblizajek, MD · Mayo Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-11
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06941545 on ClinicalTrials.gov